Innovation Challenge: ESRD Challenge Application Form
Basic Criteria for Applying
The Innovation Pathway is intended for pioneering medical devices that address unmet public health needs. The electronic application form is an opportunity to succinctly describe what is novel about your product, how it is expected to address an unmet public health need, and its expected benefit to patients, public health, access to healthcare, and/or the state of medical science.
The ESRD Innovation Challenge
The "ESRD Innovation Challenge" is a pilot program to test FDA's Innovation Pathway 2.0, and is intended for devices that address endstage renal disease (ESRD), a disease that affects hundreds of thousands of Americans, disproportionately impacts minorities, and is increasing among people ages 45 to 64. We are looking for medical device technologies that are at any stage of development that are intended to help patients with ESRD. This pilot will test the tools and processes being developed for the Innovation Pathway and will help the FDA assess the strengths and weaknesses of the Innovation Pathway program and fine-tune it for broader application.
What You Can Expect After You Apply
The application is intentionally brief in order to lower the barrier to applying. Within 14 calendar days after receiving your completed application, FDA will contact you in order to set up a time to discuss the application further. The final evaluation of your application will be based on both the written application and our discussion with you.
If your application is accepted into the Innovation Pathway, FDA will establish a collaborative partnership with you to find ways to appropriately shorten the time and reduce the cost to commercialization.
If accepted, the process will begin with the Collaboration Phase, an agreed-upon period of interaction (not to exceed 120-days) the goals of which will be 1) to create a mutual understanding of the product, the patient and user needs, the important risks and benefits; and 2) to establish the regulatory pathway forward. Since one of the goals of the Innovation Pathway is to transform how FDA does business with innovators, your experience with us will involve a greater degree of interaction with FDA staff, management, and leadership.
In most cases, applicants will eventually submit one or more formal applications to FDA, such as pre-IDE, IDE, and PMA. Each of these will receive priority review and will include efforts to appropriately shorten time and reduce cost to commercialization, in addition to our normal focus on demonstrating reasonable assurance of safety and effectiveness. Applications accepted onto the Innovation Pathway will automatically be given expedited PMA review (if Class III).
There may be additional levels of publicity around your application. FDA will get prior clearance from you on any public statements it makes about your application. In addition, FDA may propose previously untested approaches and will seek your concurrence before proceeding.
Assuming your application meets the basic requirements, additional consideration will be given to those applications that:
- demonstrate commitment to doing first-in-man and pivotal clinical trials first in the US;
- demonstrate commitment to commercialize your device first in the US; and/or
- give FDA an opportunity to improve challenging regulatory policies and/or internal practices.
CDRH will conduct an initial review within 14 days. As part of that review, you will be contacted for an initial teleconference to provide additional clarification to the review team. Following completion of the initial review, a prioritization step may be conducted and final decision made. You will be notified of the status of your application with the following possible outcomes:
- NOT ACCEPTED: If your application is not accepted into the Innovation Pathway program, we will contact you to provide an explanation for our decision and suggest next steps for you.
- ACCEPTED: If your application is accepted into the Innovation Pathway program, we will contact you to schedule a teleconference and establish a starting date for engagement on the Innovation Pathway.
- Company — Name, Address, Name of contact, Phone number, Email address
- Device name
Design concept — What is your product and how will be used?
- Brief device description
- Intended function
- Intended patient population
- Intended clinical use, designated by the disease state or condition to be treated or diagnosed
- Special patient populations (e.g., pregnant women, infants and children, immunosuppressed persons, elderly, specific comorbidities such as diabetes or hypertension)
- d. Technology / How performance is achieved (i.e., key design features for the mechanism of action)
- e. Links to videos that may help us understand how the device will be used. (If these are not publicly available, they may be requested in advance of the Initial Teleconference).
Clinical considerations — What clinical impact, risks and benefits may be associated with the use of your device (500 words)?
- Identify the unmet need and briefly explain how your device addresses the need. Include in your discussion any implications for special populations.
- Discuss the potential clinical impact of your device on individual patients, the public health landscape, access to care or other factors that make your proposal compelling.
- Identify approved alternative devices or procedures and, if so, briefly describe their availability and adequacy for the proposed use.
- Describe the risk to the intended population if there were no new devices. Please include in your response an exploration of the target population's ongoing risks in the absence of new developments.
Other factors — What other scientific, technical, medical or public health information helps define the critical importance of your device? (500 words. This is your opportunity to describe any other factors that you believe will make your application more compelling, including indirect effects on the state of science or impact on regulatory landscape.)
Development status — What is the current state of development of your device?
- Does a prototype device exist?
- Have you initiated bench and/or animal testing?
- Have you conducted an early clinical feasibility study?
Marketing and regulatory history — Have there been any regulatory submissions and/or has the device been marketed for any indication?
- a. If the device has a marketing history outside of the US, please describe briefly and specify the indication and marketing status (100 words)
- b. If the device has a marketing history inside the US, specify the indication, application number, and marketing status (100 words)
Manufacturing — What is your current manufacturing capability?
- Does your firm have prior inspectional history with FDA?
- Do you have the ability to produce prototype devices?
- Do you have the ability to produce commercial-scale GMP-compliant lots of your device?
Reason for applying — What value do you expect from your participation in the Innovation Pathway? (300 words)
Anticipated regulatory filings — Please describe the approximate sequence of the regulatory filings (e.g., pre-IDE(s), IDE(s), marketing application(s)) you anticipate submitting to FDA, and indicate whether you intend to conduct clinical trials in the US. (100 words)
When are you available for an Initial Teleconference with FDA to discuss your application? (Please provide a range of times in the next two weeks.)
If accepted onto the Innovation Pathway, when would you be ready to begin the Collaboration Phase?
Please submit your application by email to: InnovationChallenge@fda.hhs.gov